Title:  Study Start-up Lead

Study Start-up Lead (Addlestone, UK)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

This is a permanent role based in Addlestone, UK. This position is hybrid with the expectation to be in office once per quarter.

Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

• This position is accountable for the direct management of assigned study start-up related staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• Accountable for the identification, onboarding, training and development of study start-up talent to support the planning, initiation, and execution of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
• This position is accountable to the Head, Study Start-up, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of staff during execution of development trials.
• This position provides functional leadership and management globally of < 12 direct reports.

Role and Responsibilities

• Responsible for resource planning, recruitment, mentoring, development and retention of study start-up staff.
• Manages and allocates study start-up resources to trials and monitor performance on assigned trials for staff (up to 12 direct reports).
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports.
• Provides oversight and guidance in completing study start-up related activities according to agreed timelines and quality standards, including identifying areas for additional training and development.
• Oversees adherence to timelines, standards, processes for work assigned to their staff.
• Serves as a point of escalation for study start-up related topics or issues from their staff.
• Responsible for compliance of direct reports with training and identification and support for any training needs.
• Facilitates and supports global trial study start-up operational standards and tools.
• Anticipates, recognizes and facilitates problem solving to support staff and rapidly addresses and mitigates potential performance issues.

Continue:Role and Responsibilities

• Collaborates effectively with Portfolio Operations Leads and Clinical Operations Leads, to ensure study start up staff are delivering as expected and to ensure common framework and standards across clinical programs and trials.
• Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross functionally and regionally, including relevant counterparts globally, to align on best practices for study start-up staff.
• Identifies, escalates, and facilitates process improvements relevant to study start-up activities
• Contributes to development and implementation of best-in-class study start-up standards and processes.
• Responsible for overseeing, developing and aligning resources to ensure effective start-up of clinical trials and a robust talent pool.

Essential Qualifications

• BA/BS degree
• Seasoned experience executing global drug development programs and trials.
• Proven experience in study start-up activities, combined with direct people management experience.
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
• Must have extensive expertise in study start-up strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
• Must have experience working across multiple phases of development and in multiple therapeutic areas.
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and conducting global clinical programs.
• Must have proven leadership skills and effective written and verbal communication skills
• Fluent in English and in the local language.
• Moderate (~30%) travel required.

Preferred Qualifications

• Advanced Degree.
• Experience managing teams in the APAC and/or EU regions is highly desirable.
• Knowledge of EU CTR submission is an advantage.

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. 
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. 
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. 

Learn more at Astellas.com

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We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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